The FOCUS Program:The FOCUS Program:Helping Cancer Patients and Family Helping Cancer Patients and Family

Their CaregiversTheir Caregivers

Laurel Northouse PhD, RN, FAANProfessor of Nursing

University of Michigan

Co-director, Socio-behavioral ProgramU of M Comprehensive Cancer Center

OverviewOverview

Significance of the Research

Description of the FOCUS Program

Results from Three Randomized Trials

Dissemination Plans

Significance of ResearchSignificance of Research

The effects of cancer extend from patients to family caregivers

Like a stone dropping in a pond …

Reciprocal Relationship in PartnersReciprocal Relationship in Partners’’Emotional Distress Emotional Distress

Patient r = .29 Spouse

Couples react as an “emotional system”

PatientsPatients’’ Symptoms Affect Spouses Symptoms Affect Spouses

As patients’ symptoms increase, spouses report a decrease in quality of life

Patient symptoms Spouse Effect

Urinary incontinence Social quality of life

Erectile dysfunction Sexual satisfaction

Fatigue Quality of life

Emotional Toll on Spouse CaregiversEmotional Toll on Spouse Caregivers

Spouses report more symptoms of depression than patients in advanced phase of illness

Clinical Depression p valuePatients 23% <.0001Spouses 39%

Braun et al. JCO 2007

Why Help Family Caregivers of Why Help Family Caregivers of Cancer Patients?Cancer Patients?

Affected by illness -- “co-suffers”

Lack preparation for caregiving role

Little support from health professionals

Distressed caregiver hinders patient’s adjustment

Description of the FOCUS ProgramDescription of the FOCUS Program

q

Delivered by a Masters-prepared nurse

Core Program Content Core Program Content

F = Family Involvement

O = Optimistic Attitude

C = Coping Effectiveness

U = Uncertainty Reduction

S = Symptom Management

F = Family InvolvementF = Family Involvement

Promote open communicationEncourage mutual support and teamworkIdentify family strengthsHelp children in the family to cope

Promote Family CommunicationPromote Family Communication

O = Optimistic AttitudeO = Optimistic Attitude

Encourage optimistic thinkingSharing fears and negative thoughtsMaintaining hope

Optimism BrochureOptimism Brochure

C = Coping EffectivenessC = Coping Effectiveness

Help them cope with stressEncourage healthy lifestyle behaviorsIdentify possible benefits of illness

Help Families CopeHelp Families Cope

U = Uncertainty ReductionU = Uncertainty Reduction

Provide information about treatments and medication

Teach them how to obtain information from professionals or other trusted sources

Help them live with uncertainty

S = Symptom ManagementS = Symptom Management

Assess symptoms in patient and family caregiver

Teach them self-care strategies

Teach Symptom Management

Treatment FidelityTreatment Fidelity

Nurses followed a 21-page protocol checklist of interventions

Nurses audio-taped randomly selected sessions

Nurses gave case presentations at monthly intervention meetings

Intervention TeamIntervention TeamMastersMasters--prepared Nursesprepared Nurses

Completed 42-hour training programViewed FOCUS training videoNew nurses accompanied experienced

nurses on home visits to learn roleNurses maintained own caseload of

couples

Evaluation of FOCUS ProgramEvaluation of FOCUS Program

Breast Cancer Clinical TrialAmerican Cancer Society

Prostate Cancer Clinical TrialNational Cancer Institute

Advanced Cancer Clinical TrialNational Cancer Institute

The FOCUS Study The FOCUS Study –– Initial TrialInitial Trial

Recurrent Breast Cancer Patients and Recurrent Breast Cancer Patients and Family CaregiversFamily Caregivers

Funded by AmericanCancer Society

Sample: 134 patientsand their caregivers

Purpose of StudyPurpose of Study

To test the effects of a family intervention (FOCUS Program) on patient and spouse outcomes

Appraisal variables

Coping resources

Quality of life

STRESSSTRESS--COPING FRAMEWORKCOPING FRAMEWORK

OutcomesMediatorsAntecedents

Factors• Person• Social• Disease treatment

Appraisal• Threat• Hopelessness• Uncertainty

Coping Resources

• CopingStrategies

Quality of Life

• Patient• Caregiver

FOCUS

Study DesignStudy DesignRandomized Clinical TrialRandomized Clinical Trial

Control Group Experimental Group

“Standard Care”“Standard Care”

+FOCUS Program

Eligible Couples

Random Assignment

Program DeliveryProgram Delivery

Initial Phase Booster Phase

HomeVisit

1

HomeVisit

2

HomeVisit

3

PhoneCall

1

PhoneCall

2

Study ResultsStudy ResultsIntervention Intervention vsvs ControlsControls

PatientsLess negative appraisal of illness F = 4.49, p = .04

Less hopelessness F = 9.48, p = .002

CaregiversLess negative view of caregiving F = 3.90, p = .04

Northouse et al., Psycho-Oncology, 2005

FOCUS Study FOCUS Study –– Second Trial Second Trial Adapted to Prostate CancerAdapted to Prostate Cancer

N = 222 dyads

Includes 3 phases of prostate cancer

Funded by the National Cancer InstituteFunded by the National Cancer Institute

STRESSSTRESS--COPING FRAMEWORKCOPING FRAMEWORK

OutcomesMediatorsAntecedents

Factors• Person• Social• Disease treatment

Appraisal• Threat• Hopelessness• Uncertainty

Coping Resources

• Coping strategy• Self-efficacy• Communication

Quality of Life

• Patient• Caregiver

FOCUS

Study DesignStudy DesignRandomized Clinical TrialRandomized Clinical Trial

Control Group Experimental Group

“Standard Care”“Standard Care”

+FOCUS Program

Eligible Couples

Random Assignment

Stratified by:• Research Site• Phase of Illness• Treatment

FOCUSProgram

Phone Call

Delivered over three-month period

Revised Program Delivery

Phone Call

Home visit

Homevisit

Home visit

5 contacts

Longitudinal AssessmentsLongitudinal Assessments

Baseline 4 mo. 8 mo. 12 mo.Time 1 Time 2 Time 3 Time 4

Interventionor

Control

Prostate Study Results: PatientsProstate Study Results: PatientsIntervention Intervention vsvs ControlsControls

Less uncertainty F = 3.69, p = .03

Better communication F = 3.48, p = .03

Higher quality of life F = 3.21, p = .07

No differences: appraisal of illness, hopelessness, symptoms, or self-efficacy

Northouse et al. Cancer, 2007

Prostate Study Results: SpousesProstate Study Results: SpousesIntervention Intervention vsvs ControlsControls

Less negative appraisal F = 8.54, p = .002

Less hopelessness F = 4.15, p = .03

Less uncertainty F = 7.43, p = .009

More self-efficacy F = 3.83, p = .02

Better communication F = 9.71, p = .002

Higher quality of life F = 8.91, p = .004

Satisfaction with InterventionSatisfaction with Intervention

Patients’ mean satisfaction score = 4.5

Spouses’ mean satisfaction score = 4.5

Satisfaction Scores1————————————————5

low high

What did we learn?What did we learn?

Both patients and caregivers benefit from an intervention

Some participants need the intervention more than others

Rethink the “one-size-fits-all”interventions

Examine risk-for-distress and intervention dose

Current StudyCurrent StudyRisk for Distress and Intervention DoseRisk for Distress and Intervention Dose

Aim 1. Compare two doses of family intervention vs. control

Aim 2. Examine effect of patient “risk for distress”on study outcomes

Current Study Design

Screening for Risk for DistressScreening for Risk for Distress

Assesses risk of future emotional distress

A multi-dimensional scale

Predicted high and low distress in 73% of patients screened at baseline

Determining Risk StatusDetermining Risk Status

Range of Risk for Distress Scores0 ———————————————— 24low high

8 and below

9 and above

Preliminary results from current study: Range of RFD scores: 1 to 19

SampleSample

Advanced cancer patients and caregiversTarget: 475 patient-caregiver dyadsCurrently enrolled: 440 dyads

Enrollment rate: Overall 68% Retention rate: 69%

Data Collection and Intervention

Study Still in ProgressStudy Still in Progress

Enrollment should be completed May, 2009Results of Randomized Clinical Trial

available in Fall, 2009.

Translation Efforts to DateTranslation Efforts to Date

Prostate FOCUS program will be available on NCI Cancer Planet web-site (coming soon)

• Intervention protocol• Staff training manual• All brochures and handouts

Plans to translate program to tailored web-based program

Future Dissemination Plans:Future Dissemination Plans:FOCUS ProgramFOCUS Program

Research funding to facilitate translation to clinical and community settings

Analysis of cost savings and cost of delivery

Consider application to other chronic illnesses

SummarySummary

Testing family-based interventionsIdentifying families at risk of distressExamining intervention doseTranslating intervention to practice